NCT01258361已完成不适用
Echocardiographic Assessment of Volume Variation Secondary to Preoperative Fasting
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The presence / absence of a hypovolemia following preoperative fasting
研究概览
简要总结
The primary objective of this study is to demonstrate that preoperative fasting does not increase the rate of lowered blood volume (defined by a variation of 15% ΔITV during a leg lift) in patients undergoing surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is ASA (American Society of Anesthesiologists) class I, II or III
- •The patient has not been fasting for more than 6 hours at the time of inclusion
- •The patient is schelduled for a gynecological or visceral surgery
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant
- •The patient is breastfeeding
- •The patient is ASA class IV
- •The patient has insulin dependent diabetes
- •The patient has a cardiac or respiratory dysfunction
- •The patient has a heart rhythm disorder
- •The patient has renal insufficiency with dialysis
- •The patient is being treated with diuretics
- •The patient has had a bowel preparation
- •Emergency surgery
- •Outpatient surgery
结局指标
主要结局
The presence / absence of a hypovolemia following preoperative fasting
时间窗: 1 day
Hypovolemia is determined by the % change in the subaortic velocity time integral during a leg lift before and after fasting: a 15% decrease is considered as a "presence".
次要结局
未报告次要终点
研究者
研究点 (1)
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